For the Consumer

In addition to its needed effects, some unwanted effects may be caused by alprazolam (the active ingredient contained in Alprazolam Intensol). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking alprazolam:

More common

Being forgetful

changes in patterns and rhythms of speech

clumsiness or unsteadiness

difficulty with coordination

discouragement

drowsiness

feeling sad or empty

irritability

lack of appetite

lightheadedness

loss of interest or pleasure

relaxed and calm

shakiness and unsteady walk

sleepiness or unusual drowsiness

slurred speech

tiredness

trouble concentrating

trouble in speaking

trouble performing routine tasks

trouble sleeping

unsteadiness, trembling, or other problems with muscle control or coordination

Some of the side effects that can occur with alprazolam may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Seizures, hallucinations, and depersonalization have been reported in less than 1% of patients. Amnesia, psychomotor impairment, anterograde memory loss, and ataxia have also been reported.

Elderly patients and/or patients with liver dysfunction may be particularly sensitive to central nervous system side effects. The smallest effective dose should be used in the elderly to avoid the development of ataxia and oversedation.[Ref]

One study has reported that the frequency of ataxia in patients treated for panic disorder ranges between 17% and 24%. Another study has reported that patients treated acutely with alprazolam by intravenous administration experience a 25% to 30% decrease in whole brain cerebral blood flow. The decrease in blood flow is associated with memory impairment, a decrease in plasma epinephrine and a decrease in self-rated alertness. After a week of daily alprazolam therapy, most of the subjects developed tolerance to these effects.

A 64-year-old man with a history of renal insufficiency was diagnosed with nonconvulsive status epilepticus following abrupt withdrawal of yearlong alprazolam therapy at dosage 1 mg orally every night. The patient recovered with short-term oral anticonvulsant therapy and reinstitution of alprazolam followed by a more gradual taper of alprazolam therapy.

The following nervous system side effects have been reported to result in discontinuation of treatment in over 5% of patients and at a greater rate than placebo: insomnia (29.5%), lightheadedness (19.3%), anxiety (19.2%), fatigue and tiredness (18.4%), abnormal involuntary movement (17.3%), headache (17.0%), irritability (10.5%), cognitive disorder (10.3%), muscular twitching (6.9%), impaired coordination (6.6%), muscle tone disorders (5.9%), and weakness (5.8%), memory impairment (5.5%), depression (5.1%), and confused state (5.0%).

There have been reports of seizures in patients following rapid decrease in dose or abrupt withdrawal of treatment with alprazolam. The risk of withdrawal seizures may be higher in patients receiving doses greater than 4 mg per day.[Ref]

Other

Other side effects reported during treatment for anxiety disorder have included weight gain (2.7%) and weight loss (2.3%).

Other side effects have included withdrawal symptoms following either abrupt cessation or fast tapering of alprazolam (the active ingredient contained in Alprazolam Intensol) Withdrawal symptoms may include agitation, restlessness, anxiety, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating. The incidence is unknown but may be higher than for other benzodiazepines.[Ref]

In addition, some investigators have reported the following effects as manifestations of alprazolam withdrawal: confusion, clouded sensorium, heightened sensory perception, dysosmia, paresthesias, diarrhea, and decreased appetite. Psychosensory symptoms such as depersonalization, derealization, and perceptual distortion have been reported as being unique to the withdrawal syndrome.

Some investigators have suggested that the incidence of withdrawal symptoms may be related to the rapidity of dosage tapering.

A recent review of both human and nonhuman experience with alprazolam abuse potential has concluded that the abuse liability of alprazolam is probably not greater than other commonly used benzodiazepines.[Ref]

Ocular

Ocular side effects have included blurred vision (6.2% to 21%) and acute worsening of narrow angle glaucoma. Diplopia has been reported rarely (less than 1%).[Ref]

Blurred vision appears to be the reason for discontinuation of therapy in 10.0% of patients.[Ref]

Psychiatric

Psychiatric side effects reported during treatment for panic disorder have included major depression (12.1% to 13.8%).

Alteration of taste has been reported in less than 1% of patients.[Ref]

Gastrointestinal side effects which resulted in discontinuation of treatment in over 5% of patients and at a greater rate than placebo have included nausea/vomiting (16.5%), diarrhea (13.6%), and decreased salivation (10.6%).[Ref]

General

In general, if they occur, side effects are observed at the beginning of therapy and usually resolve with continuation of therapy.

Consumer resources

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